Overview
Nitroglycerin, also known as glyceryl trinitrate, is an organic nitrate and a vasodilating agent that was first discovered in 1847. Originally used to dynamite, its antianginal effects were identified in the late 1860s after it produced headaches in factory workers while workers with angina pectoris or heart failure experienced relief from chest pain. Its use as a treatment for angina dates back to 1879 and is still used to treat and prevent angina. Nitroglycerin causes vasodilation in both arteries and veins. Nitroglycerin is used in a variety of different conditions, including angina pectoris due to coronary artery disease, peri-operative hypertension, congestive heart failure, and chronic anal fissure. It is also used to induce intraoperative hypotension.
Indication
Sublingual nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. Intravenous nitroglycerin is indicated for the treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta (β)-blockers; and for induction of intraoperative hypotension. Topical nitroglycerin ointment is used to treat moderate to severe pain associated with chronic anal fissure.
Associated Conditions
- Angina Attacks
- Angina Pectoris
- Congestive Heart Failure (CHF)
- Perioperative Hypertension
- Moderate to severe pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/04 | Phase 1 | Not yet recruiting | |||
2025/04/13 | Not Applicable | Not yet recruiting | Minia University | ||
2025/04/04 | Phase 3 | Completed | University of Medicine and Pharmacy "Victor Babes" Timisoara | ||
2024/11/11 | Phase 4 | Not yet recruiting | Copenhagen University Hospital, Hvidovre | ||
2024/10/11 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2024/05/24 | Phase 4 | Recruiting | |||
2024/03/04 | Phase 2 | Not yet recruiting | |||
2024/02/20 | Not Applicable | Not yet recruiting | |||
2024/02/14 | N/A | Recruiting | |||
2023/10/30 | Phase 2 | ENROLLING_BY_INVITATION |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sigmapharm Laboratories, LLC | 42794-213 | SUBLINGUAL | 0.6 mg in 1 1 | 5/15/2018 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1019 | SUBLINGUAL | 0.4 mg in 1 1 | 3/29/2022 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1386 | INTRAVENOUS | 5 mg in 1 mL | 2/19/2024 | |
| Espero Pharmaceuticals, Inc. | 70007-400 | SUBLINGUAL | 400 ug in 1 1 | 6/30/2016 | |
| Dr. Reddys Laboratories Inc | 43598-436 | SUBLINGUAL | 0.4 mg in 1 1 | 2/10/2017 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-639 | SUBLINGUAL | 0.4 mg in 1 1 | 10/21/2021 | |
| Henry Schein, Inc. | 0404-9928 | INTRAVENOUS | 5 mg in 1 mL | 11/13/2023 | |
| Cosette Pharmaceuticals, Inc. | 0713-0564 | RECTAL | 4 mg in 1 g | 2/21/2024 | |
| Aurobindo Pharma Limited | 59651-659 | SUBLINGUAL | 0.6 mg in 1 1 | 11/1/2023 | |
| Graceway Pharmaceuticals, LLC | 29336-322 | TRANSDERMAL | 5 mg in 1 d | 11/23/2009 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RECTOGESIC OINTMENT 0.2% w/w | SIN12240P | OINTMENT | 0.2% w/w | 3/27/2003 | |
| GLYTRIN SPRAY | SIN09161P | SPRAY | 400 mcg/spray | 1/21/1997 | |
| GLYCERYL TRINITRATE-HAMELN INJECTION 1MG/ML | SIN15105P | INFUSION, SOLUTION | 1.000 MG/ML | 10/20/2016 | |
| MYONIT INSTA NITROGLYCERIN SUBLINGUAL TABLETS USP 0.5MG | SIN15702P | TABLET | 0.5mg | 5/31/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ANGININE glyceryl trinitrate 600microgram tablet bottle | 227783 | Medicine | A | 2/19/2015 | |
| RECTOGESIC glyceryl trinitrate 0.2% w/w ointment tube. | 108254 | Medicine | A | 9/9/2004 | |
| GLYCERYL TRINITRATE CONCENTRATED INJECTION PHEBRA glyceryl trinitrate 50 mg/10 mL concentrated injection vial | 453908 | Medicine | A | 5/22/2025 | |
| GLYCERYL TRINITRATE WKT glyceryl trinitrate 50 mg/50 mL concentrated solution for injection vial | 301499 | Medicine | A | 5/7/2019 | |
| TRANSIDERM-NITRO 50 glyceryl trinitrate 50 mg transdermal drug delivery system sachet | 17105 | Medicine | A | 10/2/1991 | |
| DBL GLYCERYL TRINITRATE 50mg/10mL Injection | 16341 | Medicine | A | 10/8/1991 | |
| MINITRAN 15 glyceryl trinitrate 15mg/24 hour transdermal drug delivery system, sachet | 52030 | Medicine | A | 8/8/1995 | |
| RECTOGESIC OINTMENT glyceryl trinitrate 0.2% w/w ointment tube | 66382 | Medicine | A | 10/13/1998 | |
| MINITRAN 10 glyceryl trinitrate 10mg/24 hour transdermal drug delivery system, sachet | 52029 | Medicine | A | 8/8/1995 | |
| Anginine Tablets | 11086 | Medicine | A | 8/2/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APO-NITROGLYCERIN | 02393433 | Metered-Dose Pump - Sublingual | 0.4 MG / ACT | 9/23/2013 | |
| TRINIPATCH 0.4 | Endo Operations Ltd. | 02230733 | Patch - Transdermal | 0.4 MG / HOUR | 4/1/1999 |
| TRANSDERM-NITRO 0.8 | novartis pharmaceuticals canada inc | 02046164 | Patch (Extended Release) - Transdermal | 100 MG / SRD | 12/31/1994 |
| NITROGLYCERIN INJECTION USP | mont-pharma inc | 02541033 | Solution - Intravenous | 50 MG / 10 ML | N/A |
| TRANSDERM-NITRO 0.6 | novartis pharmaceuticals canada inc | 02046156 | Patch (Extended Release) - Transdermal | 0.6 MG / HOUR | 12/31/1994 |
| MYLAN-NITRO PATCH 0.6 | Mylan Pharmaceuticals ULC | 02407469 | Patch (Extended Release) - Transdermal | 0.6 MG / HOUR | 6/4/2013 |
| HOMEO-FORM MI-TAB | homeocan inc. | 02149362 | Tablet - Oral | 6 X | 12/31/1995 |
| NITROGARD-SR TAB 1MG | astra pharma inc. | 00749362 | Tablet (Extended-Release) - Buccal | 1 MG | 12/31/1987 |
| ARIBOSAN B31 - LIQ | professional health products | 02158876 | Liquid - Oral | 6 D / ML | 12/31/1996 |
| NITROJECT INJ 1MG/ML | omega laboratories limited | 00614262 | Solution - Intravenous | 10 MG / 10 ML | 12/31/1990 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| NITRODERM TTS 5 PARCHES TRANSDERMICOS | Bexal Farmaceutica S.A. | 57358 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| DERMATRANS 10 mg/24 H PARCHE TRANSDERMICO | Casen Recordati S.L. | 63682 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| NITRODERM TTS 10 PARCHES TRANSDERMICOS | Bexal Farmaceutica S.A. | 57359 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| NITROFIX 15 mg PARCHES TRANSDERMICOS EFG | Arafarma Group S.A. | 71214 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| TRINIPATCH 15 mg/ 24 HORAS PARCHES TRANSDÉRMICOS | 61697 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| NITROFIX 5 mg PARCHES TRANSDERMICOS EFG | Arafarma Group S.A. | 71209 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| TRINIPATCH 10 mg/ 24 HORAS PARCHES TRANSDÉRMICOS | 61696 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| EPINITRIL 5mg / 24H PARCHES TRANSDERMICOS | 63676 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| CORDIPLAST 10 mg/24 h PARCHES TRANSDERMICOS | Merus Labs Luxco Ii S.À.R.L. | 60314 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| MINITRAN 15 mg/24 H PARCHES TRANSDÉRMICOS | 59990 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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